Status:
RECRUITING
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Lead Sponsor:
SEED Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Ewing Sarcoma
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Detailed Description
This Phase 1/1b study is evaluating the safety, tolerability, and preliminary anticancer activity of ST-01156 in participants with advanced solid malignancies. The study will be conducted in 2 parts. ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.
- Has a metastatic or locally advanced and unresectable solid tumor.
- Has at least 1 measurable lesion or evaluable disease per RECIST v1.1.
- Has an ECOG performance status ≤ 2 at screening.
- Has adequate organ function as defined in the protocol.
Exclusion
- Has received prior radiotherapy within 2 weeks of treatment.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable
- Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.
- Had major surgery within 28 days before study therapy administration
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.
- Has previously received a RBM39 inhibitor/degrader.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT07197554
Start Date
December 1 2025
End Date
December 31 2029
Last Update
December 18 2025
Active Locations (6)
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1
The City of Hope National Medical Center
Duarte, California, United States, 91010
2
Hoag Memorial Hospital
Newport Beach, California, United States, 92263
3
Mass General Brigham Cancer Institute
Boston, Massachusetts, United States, 02114
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215